UVA Islet Cell Transplantation in Patients With Type I Diabetes

NCT00605592 | Unknown Phase 1 DMC

• 1 other identifier: 12839
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol will provide islet cell transplantation to two separate populations in need of a pancreas transplant: Group I: Islet Cell Transplantation in Type I Diabetics without Kidney Problems Group II: Islet Cell Transplantation in Type I Diabetics Who Have a Stable Functioning Kidney Transplant The targeted patients have very brittle diabetes or dangerous hypoglycemic unawareness and may benefit from transplantation over continuing insulin therapy, even though chronic immunosuppression is required. We believe that in these patients, the islet transplant procedure promises enough potential benefit to justify subjecting patients who have not previously had a transplant to the risk of immunosuppression. In patients who are already subject to the dangers of chronic immunosuppression for other reasons, i.e. to prevent rejection of a kidney allograft, the islet transplantation procedure itself is the principal additional risk and this risk should be minimal. In these patients (our Group II), the potential benefit from improved glycemic control is that it promises to slow or even reverse diabetic complications, such as vascular problems leading to kidney damage. It is this rationale that has made pancreas transplantation a widely accepted option in patients with renal failure, despite the risks associated with whole pancreas transplantation. Islet cell transplantation aims to provide a potentially lower risk procedure that has similar relief from diabetic complications.

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 Diabetes; Kidney Transplant; Hypoglycemic Unawareness; Islet Transplant; Pancreatic Islet Cell Transplantation; University of Virginia; Islet Transplantation; Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• A decrease in the average daily insulin requirement post-islet cell transplantation.

  Post-transplant

Study Arms (1)

1

EXPERIMENTAL

Islet cell transplant

Procedure: Pancreatic Islets of Langerhans Cell Transplant

Interventions

Pancreatic Islets of Langerhans Cell Transplant PROCEDURE

Transplantation of islet cells will be given to eligible patients, up to three times during the study, using cell quantities based on body weight.

Also known as: Islet Cell Transplant, Pancreatic Islet Cell Transplantation

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type I Diabetes Mellitus for at least 5 years
• Unstable control of diabetes despite intensive care by an endocrinologist, including episodes of dangerously low blood sugars
• Group I must have healthy kidneys
• Group II (islet after kidney) must have a stable kidney allograft for at least 6 months

You may not qualify if:

• Unstable diabetic eye disease
• Poor kidney function
• Type II Diabetes as determined by blood tests
• Any history of cancer, except certain skin cancers
• Pregnant or unwilling to use adequate birth control
• Very high hemoglobin A1c levels
• Poor control of blood pressure, despite use of medications
• Very high insulin requirements
• History of exposure to HIV
• Active Hepatitis B or Hepatitis C infection

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Islets of Langerhans Transplantation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Endocrine Surgical Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Kenneth Brayman, MD, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: January 31, 2008
• Study Start: January 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 18, 2009

Record last verified: 2009-02

Locations

US (1)